Transcript

PACKAGE LEAFLET

08451.0MS1.020E14

Package leaflet: Information for the user
Lipoflex special without electrolytes emulsion for infusion
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
●
Keep this leaflet. You may need to read it again.
●
If you have any further questions, ask your doctor, pharmacist or nurse.
●
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
●
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Lipoflex special without electrolytes is and what it is used for
2.
What you need to know before you use Lipoflex special without electrolytes
3.
How to use Lipoflex special without electrolytes
4.
Possible side effects
5.
How to store Lipoflex special without electrolytes
6.
Contents of the pack and other information

1.

What Lipoflex special without electrolytes is and what it is used for

Lipoflex special without electrolytes contains fluids and substances called amino acids and fatty acids that are
essential for the body to grow or to recover. It also contains calories in the form of carbohydrates and fats.
You are given Lipoflex special without electrolytes when you are unable to eat food normally. There are many
situations when this might be the case, for example when you are recovering from surgery, injuries or burns, or
when you are unable to absorb food from your stomach and gut.

2.

What you need to know before you use Lipoflex special without electrolytes

Do not use Lipoflex special without electrolytes
●
if you are allergic to any of the active substances, to egg, peanut or soybean or to any of the other
ingredients of this medicine (listed in section 6).
●
This medicine must not be given to newborn infants, infants and toddlers under two years old.
Also, do not use Lipoflex special without electrolytes if you suffer from any of the following:
●
life-threatening blood circulation problems such as those that can occur if you are in a state of collapse or
shock
●
heart attack or stroke
●
severely impaired blood clotting function, bleeding risk (severe coagulopathy, aggravating haemorrhagic
diatheses)
●
blocking of blood vessels by blood clots or fat (embolism)
●
severe liver failure
●
impaired bile flow (intrahepatic cholestasis)
●
severe kidney failure in the absence of kidney replacement therapy
●
disturbances of your body salt composition
●
fluid deficit or excess water in your body

08451.0MS1.020E14

●
●
●

water on your lungs (pulmonary oedema)
severe heart failure
certain metabolic disorders such as
– too much lipid (fat) in the blood
– inborn errors of amino acid metabolism
– abnormally high blood sugar level that needs more than 6 units of insulin per hour to be controlled
– abnormalities of metabolism that may occur after operations or injuries
– coma of unknown origin
– insufficient supply of oxygen to tissues
– abnormally high acid level in the blood.

Warnings and precautions
Talk to your doctor before using Lipoflex special without electrolytes.
Please inform your doctor if:
●
you have heart, liver or kidney problems
●
you suffer from certain types of metabolic disorders such as diabetes, abnormal blood fat values and
disorders of your body fluid and salt composition or your acid-base balance
You will be monitored closely to detect early signs of an allergic reaction (such as fever, shivering, rash, or
shortness of breath) when you receive this medicine.
Further monitoring and tests such as various examinations of blood samples will be applied to make sure that
your body handles the administered foodstuffs properly.
This medicine is an electrolyte free solution. Your healthcare professional will take measures to ensure that
your body’s fluid and electrolyte requirements are met. In addition to this medicine you will receive further
nutrients (foodstuffs) in order to fully cover your requirements.
Children
This medicine must not be given to newborn infants, infants and toddlers under two years old.
Other medicines and Lipoflex special without electrolytes
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Lipoflex special without electrolytes can interact with some other medicines. Please tell your doctor if you are
taking or receiving any of the following:
●
insulin
●
heparin
●
medicines that prevent undesirable blood clotting such as warfarin or other coumarin derivatives
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor for advice before taking this medicine. If you are pregnant, you will receive this medicine only if the
doctor considers it absolutely necessary for your recovery. There is no data available about the use of Lipoflex
special without electrolytes in pregnant women.
Breast-feeding is not recommended for mothers on parenteral nutrition.

08451.0MS1.020E14

Driving and using machines
This medicine is normally given to immobile patients , e.g. in a hospital or clinic which would exclude driving
or using machines. However, the medicine itself has no effect on the ability to drive or use machines. Lipoflex
special without electrolytes contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per multichamber bag, i.e. it is essentially ‘sodiumfree’.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
3.

How to use Lipoflex special without electrolytes

This medicine is administered by intravenous infusion (drip), that is, through a small tube directly into a vein.
This medicine will be administered through one of your large (central) veins only.
Your doctor will decide how much of this medicine you need and for how long you will require treatment with
this medicine.
Use in children
This medicine must not be given to newborn infants, infants and toddlers under two years old.
If you use more Lipoflex special without electrolytes than you should
If you have received too much of this medicine you may suffer from a so-called ‘overload syndrome’ and the
following symptoms:
●
fluid excess and electrolyte disorders
●
water on your lungs (pulmonary oedema)
●
loss of amino acids through the urine and disturbed amino acid balance
●
vomiting, feeling sick
●
shivering
●
high blood sugar level
●
glucose in the urine
●
fluid deficit
●
blood much more concentrated than normal (hyperosmolality)
●
impairment or loss of consciousness due to extremely high blood sugar
●
enlargement of the liver (hepatomegaly) with and without jaundice (icterus)
●
enlargement of the spleen (splenomegaly)
●
fat deposition in the inner organs
●
abnormal values of liver function tests
●
reduction of red blood cell count (anaemia)
●
reduction of white blood cell count (leucopenia)
●
reduction of blood platelet count (thrombocytopenia)
●
increase of immature red blood cells (reticulocytosis)
●
rupture of blood cells (haemolysis)
●
bleeding or a tendency to bleeding
●
impairment of blood coagulation (as can be seen by changes of bleeding time, coagulation time,
prothrombin time etc.)
●
fever

08451.0MS1.020E14

●
●

high blood fat levels
loss of consciousness

If any of these symptoms occur, the infusion must be stopped immediately.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may be serious. If any of the following side effects occur, tell your doctor
immediately, he will stop giving you this medicine:
Rare (may affect up to 1 in 1,000 people):
●
allergic reactions, for example skin reactions, shortness of breath, swelling of the lips, mouth, and throat,
difficulty breathing
Other side effects include:
Uncommon (may affect up to 1 in 100 people):
●
feeling sick, vomiting, loss of appetite
Rare (may affect up to 1 in 1,000 people):
●
increased tendency for your blood to clot
●
bluish discolouration of the skin
●
shortness of breath
●
headache
●
flushing
●
reddening of skin (erythema)
●
sweating
●
chills
●
feeling cold
●
high body temperature
●
drowsiness
●
pain in the chest, back, bones or lumbar region
●
decrease or increase in blood pressure
Very rare (may affect up to 1 in 10,000 people):
●
abnormally high blood fat or blood sugar values
●
high levels of acidic substances in your blood
●
Too much lipid can lead to fat overload syndrome, for more information on this please see under the
heading “If you use more Lipoflex 56/144 special without electrolytes than you should” in section 3.
Symptoms normally disappear when the infusion is stopped.
Not known (frequency cannot be estimated from the available data):
●
reduction of white blood cell count (leucopenia)
●
reduction of blood platelet count (thrombocytopenia)
●
impaired bile flow (cholestasis)
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this
leaflet.

08451.0MS1.020E14

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Lipoflex special without electrolytes

Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Do not freeze. If accidentally frozen, discard the bag.
Keep the bag in the protective overwrap in order to protect from light.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day
of that month.
6.

Contents of the pack and other information

What Lipoflex special without electrolytes contains
The active substances in the ready-for-use mixture are:
from the top chamber
(glucose solution)
Glucose monohydrate
equivalent to anhydrous glucose

Amino acid content
Nitrogen content
Carbohydrate content
Lipid content
Energy in the form of lipids
Energy in the form of carbohydrates
Energy in the form of amino acids
Non-protein energy
Total energy
Osmolality
Theoretical osmolarity
pH

Figure A: The multichamber bag is packed in a protective overwrap. An oxygen absorber and an oxygen

08451.0MS1.020E14

indicator are placed between the bag and the overwrap; the oxygen absorber sachet is made of inert material
and contains iron hydroxide.
Figure B: The top chamber contains a glucose solution, the middle chamber contains a fat emulsion, and the
bottom chamber contains an amino acid solution.
The glucose and the amino acid solutions are clear and colourless or straw-coloured. The fat emulsion is milkywhite.
The top chamber and the middle chamber can be connected with the bottom chamber by opening the
intermediate seams.
The different container sizes are presented in cartons containing five bags.
Pack sizes: 5 x 625 ml, 5 x 1250 ml and 5 x 1875 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Str. 1
34212 Melsungen, Germany

__________________________________________________________________________
The following information is intended for healthcare professionals only:
No special requirements for disposal.
Parenteral nutrition products should be visually inspected for damage, discolouration and emulsion instability

08451.0MS1.020E14

before use.
Do not use bags which are damaged; neither overwrap nor the primary bag should be damaged. Use only if the
peel seams between the chambers are intact, if amino acid and glucose solutions are clear and colourless up to
straw coloured and the emulsion is a homogenous liquid with milky white appearance. Do not use if the
solutions are discoloured or contain particulate matter. Do not use if the emulsion shows signs of phase
separation (oil drops, oil layer).
Before opening the overwrap, check the colour of the oxygen indicator (see Figure A). Do not use if the oxygen
indicator is pink. Use only if the oxygen indicator is yellow.
Preparation of the mixed emulsion
Strict adherence to aseptic handling principles must be complied with.
To open: Tear overwrap starting from the tear notches (Fig. 1). Remove the bag from its protective overwrap.
Discard overwrap, oxygen indicator, and oxygen absorber.
Visually inspect the primary bag for leaks. Leaky bags must be discarded, since the sterility cannot be
guaranteed.

To open and mix the chambers sequentially, roll the bag with both hands, starting first by opening the peel
seam that separates the top chamber (glucose) and the bottom chamber (amino acids) (Fig. 2a). Then continue
applying pressure so that the peel seam separating the middle chamber (lipids) and the bottom chamber opens
(Fig. 2b).
After removing the aluminium seal (Fig. 3) one can add compatible additives via the medication port (Fig. 4).

08451.0MS1.020E14

Mix the contents of the bag thoroughly (Fig. 5) and visually inspect the mixture (Fig. 6). There should be no
signs of emulsion phase separation.
The mixture is a milky white homogenous oil-in-water emulsion.
Preparation for infusion
The emulsion should always be brought to room temperature prior to infusion.
Remove the aluminium foil (Fig. 7) from the infusion port and attach the infusion set (Fig. 8). Use a non-vented
infusion set or close the air vent when using a vented set. Hang the bag on an infusion stand (Fig. 9) and carry
out infusion using the standard technique.

For single use only. Container and unused residues must be discarded after use.
Do not reconnect partially used containers.
If filters are used they must be lipid-permeable (pore size ≥ 1.2 µm).
Shelf life after removing the protective overwrap and after mixing of the contents of the bag
After mixing the contents of the chambers the final emulsion is to be used immediately.
Shelf life after admixture of compatible additives
From a microbiological point of view, the product should be used immediately after admixture of additives. If
not used immediately after admixture of additives, in-use storage times and conditions prior to use are the
responsibility of the user.
The emulsion is to be used immediately after opening of the container.
Lipoflex special without electrolytes must not be mixed with other medicinal products for which compatibility
has not been documented. Compatibility data for different additives (e.g. electrolytes, trace elements, vitamins)
and the corresponding shelf life of such admixtures can be provided on demand by the manufacturer.
Lipoflex plus should not be given simultaneously with blood in the same infusion set due to the risk of
pseudoagglutination.
Duration of infusion of one single bag
The recommended duration of infusion for a parenteral nutrition bag is maximum 24 h.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.